Trials / Completed
CompletedNCT04904406
Changes in Weight, Body Composition and Cardiac Risk After Discontinuing Abacavir Treatment in HIV-infected Individuals
Changes in Weight and Body Composition After Switch to Dolutegravir/Lamivudine Compared to Continued Dolutegravir/Abacavir/Lamivudine for Virologically Suppressed HIV Infection: A Randomized Open-label Superiority Trial: AVERTAS-1
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 81 (actual)
- Sponsor
- Thomas Benfield · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Randomized controlled parallel open-label study in people living with HIV and at least 6 month of treatment with dolutegravir/abacavir/lamivudine prior to inclusion. Participants (n=95) are randomized to continue 3 drug-regimen dolutegravir/abacavir/lamivudine (control) or switch to two-drug regimen with dolutegravir/lamivudine (intervention). Follow-up is 48 weeks. Data is collected at baseline and week 48. Primary outcome is changes in weight from baseline of more than 2 kg. Secondary outcomes are changes in cardiac risk, composition and calcification of the heart tissue, and changes in body composition and metabolism, inflammation and coagulation. A MRI substudy is applied to focus on the cardiac adverse effects of abacavir.
Detailed description
In the MRI sub study 40 patients from the main study (20 from each group) are included. A cardiac MRI are performed at baseline and week 48 to evaluate cardiac effects of abacavir.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dolutegravir / Lamivudine Oral Tablet | Discontinuing abacavir by switching from three-drug regimen with dolutegravir/abacavir/lamivudine to two-drug regimen with dolutegravir/lamivudine |
Timeline
- Start date
- 2020-10-22
- Primary completion
- 2023-12-01
- Completion
- 2023-12-01
- First posted
- 2021-05-27
- Last updated
- 2024-05-29
Locations
2 sites across 1 country: Denmark
Source: ClinicalTrials.gov record NCT04904406. Inclusion in this directory is not an endorsement.